510(k) · Cleared
ClearedUnicap Gliadin Igg Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · MST Antibodies, Gliadin
Cleared on Oct 22, 1998 after a 94-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Oct 22, 1998
- Review
- 94 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K982533 | FDA’s K982533 is Unicap Gliadin Iga Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
| * | — | ImmuLisa™ IgG Anti-Gliadin Antibody Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MST
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MST
Too few MST 510(k)s in any year since 2007 to give a median.
Recalls per year · MST
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MST
No MAUDE report names MST since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
UniCAP Gliadin IgA/IgG ImmunoCAP™ is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. UniCAP Specific IgA is…
Read the full statement (316 words)
UniCAP Gliadin IgA/IgG ImmunoCAP™ is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.
UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgA system. UniCAP Specific IgA assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.
UniCAP Gliadin IgA/IgG ImmunoCAP™ is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.
UniCAP Specific IgG is an in vitro test system for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgG system. UniCAP Specific IgG assay is to be used with the instrument UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982701: Unicap Gliadin Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982701
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026